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The Power of Data Collection

American astrophysicist Dr. Neil deGrasse Tyson once said, “Any time scientists disagree, it’s because we have insufficient data. Then we can agree on what data to get; we get the data; and the data solves the problem. Either I’m right, you’re right or we’re both wrong.” In orthopaedics, data is king.

Since the inception of the Equinoxe® Shoulder System in 2004, Exactech and its surgeon partners have made the science of data collection part of their mission. With 35 collection sites across the United States and Europe, the Equinoxe database includes information on demographics, comorbidities, implant specifics, 7 PROMs, ROM, radiographic data, and complications—all using standardized forms—for more than 10,000 shoulder cases.  This multi-center collection using standardized forms creates the volume of evidence needed to produce the necessary statistical power for accurate analysis of the data; otherwise, the data would not be generalizable to a large patient population or to surgeons in different countries.

Some implant manufacturers and their consultants take non-standardized or under-powered data, such as individual user experience or small groups of surgeons’ outcomes, and present it as generalizable evidence. This makes it difficult for surgeons to know what they can and can’t trust. Accurate analysis of robust data is what surgeons need to make informed decisions about which implant to use and what surgical techniques to employ to do what is best for the patient.

The Journal of Bone & Joint Surgery recently published an article titled “Acromial and Scapular Fractures After Reverse Total Shoulder Arthroplasty with a Medialized Glenoid and Lateralized Humeral Implant: An Analysis of Outcomes and Risk Factors” by Routman et al. In this study, 4,125 shoulders from 3,995 patients were treated for primary reverse total shoulder arthroplasty using only one design of a reverse shoulder prosthesis1—the Equinoxe rTSA System, a medialized glenoid and lateralized humeral implant. The Equinoxe reverse acromial and scapular fracture rate is 1.48 percent, which is more than two times lower than the prosthesis designs, whether inlay or onlay, referenced in this study.2-5

Despite the comprehensive and extensive data, surgeons continue to disagree on whether implant design is associated with acromial and scapular fractures. One possible reason is that previous studies tend to lack the necessary statistical power for accurate data analysis to make the resulting claims and surgeons must depend on comparisons drawn from meta-analyses to try to answer this important question.

With the ever-increasing number of medical journals and online outlets available for publication, there should be an increased amount of scrutiny placed on editorial submissions that are accepted—and the underlying data within them—but that does not always seem to be the case.

Creating products for patients that solve clinical challenges requires dedication and investment. Over the last 17 years, Exactech surgeon collaborators and their research staffs have invested countless hours alongside Exactech’s multi-million-dollar investment to ensure that the Equinoxe Shoulder System is the most studied and published shoulder arthroplasty system on the market. The original medial glenoid lateral humerus design has not changed since its introduction—a feat that is truly unique within the industry. With over 430 literature references since 2004 and 27 peer-reviewed papers in 2020 alone, the Equinoxe database is a benchmark for new product development. It has also paved the way for continued use of the Equinoxe Shoulder System in Europe under the new EU Medical Device Regulations and enabled the use of machine learning to create predictive modeling applications and shoulder scoring systems, which will change and challenge the current way we approach shoulder surgery. The continuum of care is expanding, and data will support this growth. This is the power of the Equinoxe database.

Without clean, generalizable, sufficiently powered data, the conversation will continue to be “I’m right, you’re right or we’re both wrong”; and while this provides a platform for heated debate within the orthopaedic community and for capitalism, to prosper, the question of what is right for the patient will continue to be our guide.

Thoughts contributed by Jessica DeGrasse, Exactech, Inc.

REFERENCES

  1. Routman, HD, et al. Acromial and Scapular Fractures After Reverse Total Shoulder Arthroplasty with a Medialized Glenoid and Lateralized Humeral Implant, J Bone Joint Surg. 2020 Aug 26.
  2. Teusink MJ, et al. What is the effect of postoperative scapular fracture on outcomes of reverse shoulder arthroplasty? J Shoulder Elbow Surg. 2014 Jun;23(6):782-90. Epub 2013 Dec 8.
  3. Ascione F, et al. Increased scapular spine fractures after reverse shoulder arthroplasty with a humeral onlay short stem: an analysis of 485 consecutive cases. J Shoulder Elbow Surg. 2018 Dec;27(12):2183-90. Epub 2018 Aug 8.
  4. Levy JC, Blum S. Postoperative acromion base fracture resulting in subsequent instability of reverse shoulder replacement. J Shoulder Elbow Surg. 2012 Apr;21(4):e1 4-8. Epub 2011 Dec 21.
  5. Haidamous G, et al. The risk of postoperative scapular spine fracture following reverse shoulder arthroplasty is increased with an onlay humeral stem. J Shoulder Elbow Surg. 1-8.